Print

ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/7/2015 Axert Almotriptan Malate Janssen Pharms Teva Pharms USA
7/7/2015 Zyvox Linezolid Pharmacia and Upjohn Hospira
7/8/2015 Soma Carisoprodol Meda Pharms Indicus Pharma
7/8/2015 Pennsaid Diclofenac Sodium Nuvo Research IGI Labs
7/8/2015 Flecainide Acetate Flecainide Acetate Roxane Aurobindo Pharma
7/9/2015 Phoslo Gelcaps Calcium Acetate Fresenius Medical Lupin
7/9/2015 Macrobid Nitrofurantoin (Monohydrate/ Macrocrystals) Alvogen Watson Labs
7/10/2015 Klor-Con Pottasium Chloride Actavis Upsher Smith
7/10/2015 Viramune XR Nevirapine Boehringer Ingelheim Alvogen Pine Brook
7/10/2015 Travatan Z Travoprost Alcon Pharms Apotex
7/13/2015 Pataday Olopatadine Hydrochloride Alcon Pharms Barr Labs
7/13/2015 Zofran Ondansetron Hydrochloride Novartis Pharms Corp Accord Healthcare
7/13/2015 Tobi Tobramycin Novartis Pharms Amneal Pharms
7/14/2015 Angiomax Bivalirudin Medicines Co Hospira
7/14/2015 Angiomax Bivalirudin Medicines Co Hospira
7/14/2015 Protonix IV Pantoprazole Sodium Wyeth Sandoz
7/15/2015 Qualaquin Quinine Sulfate Mutual Pharm Co Amneal Pharms
7/15/2015 Prandimet Repaglinide / Metformin Hydrochloride Novo Nordisk Lupin
7/16/2015 Zyvox Linezolid Pharmacia and Upjohn Sandoz
7/20/2015 Bimatoprost Bimatoprost Lupin Apotex
7/21/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron MIPS CRF
7/22/2015 Qualaquin Quinine Sulfate Mutual Pharm Co RiconPharma
7/23/2015 Norvasc Amlodipine Besylate Pfizer Sovereign Pharms
7/23/2015 Brevibloc Esmolol Hydrochloride Baxter Healthcare Aurobindo Pharma
7/24/2015 Abilify Aripiprazole Otsuka Apotex
7/24/2015 Diflorasone Diacetate Diflorasone Diacetate Taro VersaPharm
7/24/2015 Niaspan Niacin Abbvie Amneal Pharms
7/24/2015 Nimodipine Nimodipine Bannar Life Sciences Sofgen Pharms
7/27/2015 Lithobid Lithium Carbonate Ani Pharms Unique Pharm Labs
7/28/2015 Astelin Azelastine Hydrochloride Meda Pharms Breckenridge Pharms
7/28/2015 Buprenex Buprenorphine Hydrochloride Indivior Par Sterile Products
7/28/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein University of Michigan
7/28/2015 Folic Acid Folic Acid Amneal Pharm/Watson Labs Nuvo Pharm
7/29/2015 Edecrin Ethacrynate Sodium Aton Par Sterile Products
7/29/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Hot Shots NM
7/30/2015 Benzonatate Benzonatate The Pharma Network Strides Arcolab
7/30/2015 Prilosec OTC Omeprazole Magnesium Astrazeneca Perrigo
7/30/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Cardnal Health 414
7/31/2015 Benzonatate Benzonatate The Pharma Network CSPC NBP Pharm
7/31/2015 Claritin Loratadine Bayer Healhcare Taro
7/31/2015 Namenda Memantine Hydrochloride Forest Labs Upsher Smith
7/31/2015 Aciphex Rabeprazole Sodium Eisai Amneal Pharms
8/3/2015 Xanax Alprazolam Pharmacia and Upjohn Aurobindo Pharma
8/3/2015 Nexium Esomeprazole Magnesium Astrazeneca Mylan Labs
8/3/2015 Zutripro Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride Cypress Pharm Coastal Pharms
8/3/2015 Advil Ibuprofen Sodium Pfizer Consumer Healthcare Perrigo
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma
8/3/2015 Singulair Montelukast Sodium Merck Ajanta Pharma 
8/3/2015 Invega Paliperidone Janssen Pharms Actavis
8/4/2015 Androgel Testosterone Abbvie Perrigo Israel
8/4/2015 Tindamax Tinidazole Mission Pharma Edenbridge Pharms
8/5/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Aurobindo Pharma
8/5/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Aurobindo Pharma
8/5/2015 Precedex Dexmethylphenidate Hydrochloride Hospira Watson Labs
8/5/2015 Fortesta Testosterone Endo Pharms Actavis
8/7/2015 Amiloride Hydrochloride Amiloride Hydrochloride Par Pharm Zydus Pharms USA
8/7/2015 Lidocaine Lidocaine Fougera Amneal Pharms
8/7/2015 Lidoderm Lidocaine Teikoku Pharma USA Mylan Technologies
8/7/2015 Mirapex ER Pramipexole Dihydrochloride Boehringer Ingelheim Dr. Reddy's
8/11/2015 Detrol LA Tolterodine Tartrate Pharmacia and Upjohn Torrent Pharms
8/12/2015 Kariva Bekyree Barr Lupin
8/12/2015 Ortho-Cept Isibloom Janssen Pharms Sandoz
8/12/2015 Levaquin Levofloxacin Janssen Pharms Hospira
8/12/2015 Cozaar Lorsartan Potassium Merck Sharp Dohme Hetero Labs
8/13/2015 Keppra Levetiracetam UCB Fresenius Kabi USA
8/13/2015 Atralin Tretinoin Dow Pharm Spear Pharms
8/14/2015 Ammonia N 12 Ammonia N 13 Feinstein Precision Nuclear
8/14/2015 Abilify Aripiprazole Otsuka Amneal Pharms
8/14/2015 Abilify Aripiprazole Otsuka Silarx Pharms
8/14/2015 Xylocaine Lidocaine Hydrochloride Fresenius Kabi USA Luitpold
8/14/2015 Methylin Methylphenidate Hydrochloride Mallinckrodt Novel Labs
8/17/2015 Yaz Drospirenone / Ethinyl Estradiol Bayer Healthcare Glenmark Pharms
8/17/2015 Fenofibrate Fenofibrate Teva Lupin
8/17/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Avanthi
8/17/2015 Xenazine Tetrabenazine Valeant Sun Pharma Global
8/18/2015 Cisplatin Cisplatin Fresenius Kabi USA Accord Healthcare
8/18/2015 Demeclocycline Hydrochloride Demeclocycline Hydrochloride Amneal Pharm  Epic Pharma
8/18/2015 Dolophine Hydrochloride Methadone Hydrochloride Roxane Corepharma
8/18/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron IBA Molecular N Am
8/19/2015 Boniva Ibandronate Sodium Roche Lupin
8/19/2015 Prilosec Omeprazole Astrazeneca Aurobindo Pharma USA
8/20/2015 Pennsaid Diclofenac Sodium Nuvo Research Lupin
8/20/2015 Rozerem Ramelteon Takeda Pharms USA Actavis
8/21/2015 Celebrex Celecoxib GD Searle Alembic Pharms
8/24/2015 Delalutin Hydroxyprogesterone Caproate Bristol-Myers Squibb McGuff
8/24/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Novel Labs
8/24/2015 Rythmol SR Propafenone Hydrochloride GlaxoSmithKline Watson Labs
8/25/2015 Focalin XR Dexmethylphenidate Hydrochloride Novartis Mylan Pharms 
8/25/2015 Prilosec Omeprazole Astrazeneca Lupin
8/26/2015 Baraclude Entecavir Bristol-Myers Squibb Aurobindo Pharma
8/26/2015 Prometh VC Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codiene Phosphate Actavis Amneal Pharms
8/28/2015 Tarceva Erlotinib Hydrochloride OSI Pharms Teva Pharms USA
8/28/2015 Lexapro Escitalopram Oxalate Forest Labs Prinston
8/28/2015 Evista Raloxifene Hydrochloride Eli Lilly Aurobindo Pharma
8/31/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein IBA Molecular N Am
8/31/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Queen Hamamatsu Pet
8/31/2015 Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide Reckitt Benckiser Actavis
8/31/2015 Dolophine Hydrochloride Methadone Hydrochloride Roxane Aurolife Pharma
8/31/2015 Avelox Moxifloxacin Hydrochloride Bayer Healthcare Mylan Pharms 
8/31/2015 Detrol Tolterodine Tartrate Pharmacia and Upjohn MacLeods Pharms
9/2/2015 Zyrtec Cetirizine Hydrochloride McNeil Consumer Par Pharm
9/2/2015 Synalar Fluocinolone Acetonide Medimetriks Pharms Gavis Pharms
9/2/2015 Vfend Voriconazole PF Prism CV Glenmark Pharms
9/3/2015 Mucinex Guaifenesin Reckitt Benckiser Actavis
9/3/2015 Levaquin Levofloxacin in Dextrose 5% in Plastic Container Janssen Pharms Hospira
9/3/2015 Exelon Rivastigmine Novartis Alvogen
9/3/2015 Micardis Telmisartan Boehringer Ingelheim Aurobindo Pharma
9/4/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Hospira
9/4/2015 Ampicillin Sodium Ampicillin Sodium Sandoz Hospira
9/4/2015 Topicort Desoximetasone Taro Actavis
9/4/2015 Keppra XR Levetiracetam UCB Dexcel Pharma
9/4/2015 Namenda Memantine Hydrochloride Forest Labs Wockhardt
9/4/2015 Singulair Montelukast Sodium Merck Amneal Pharms
9/8/2015 Giazo Balsalazide Disodium Valeant Par Pharm
9/8/2015 Micardis Telmisartan Boehringer Ingelheim Amneal Pharms
9/9/2015 Ortho Tri-Cyclenlo Norgestimate / Ethinyl Estradiol Janssen Pharms Jai Pharma
9/9/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Xellia Pharms
9/10/2015 Soriatane Acitretin Stiefel Labs Inc Mylan Pharms 
9/8/2015 Giazo Balsalazide Disodium Valeant Par Pharm
9/8/2015 Micardis Telmisartan Boehringer Ingelheim Amneal Pharms
9/9/2015 Ortho Tri-Cyclenlo Norgestimate / Ethinyl Estradiol Janssen Pharms Jai Pharma
9/9/2015 Vancomycin Hydrochloride Vancomycin Hydrochloride Fresenius Kabi USA / Hospira Xellia Pharms
9/10/2015 Soriatane Acitretin Stiefel Labs Inc Mylan Pharms 
9/11/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein MIPS CRF
9/11/2015 Lescol XL Fluvastatin Sodium Novartis Mylan Pharms 
9/15/2015 Clarithromycin Clarithromycin Teva Lupin
9/15/2015 Fazaclo ODT Clozapine Jazz Pharms Mylan Pharms 
9/15/2015 Ibuprofen Ibuprofen Dr Reddy's Granules India
9/15/2015 Mestinon Pyridostigmine Bromide Valeant Impax Labs
9/16/2015 Taxotere Docetaxel Sanofi Aventis Teva Pharms USA
9/16/2015 Allegra Fexofenadine Hydrochloride Sanofi Aventis Sciegen Pharms
9/16/2015 Allegra Fexofenadine Hydrochloride Sanofi Aventis Sciegen Pharms
9/16/2015 Lopid Gemfibrozil Pfizer Pharms Aurobindo Pharma
9/16/2015 Corgard Nadolol King Pharms Orion Corp
9/17/2015 Zomig-ZMT Zolmitriptan Astrazeneca Jubilant Generics
9/18/2015 Buspirone Hydrochloride Buspirone Hydrochloride Teva Emcure Pharms USA
9/18/2015 Precedex Dexmedetomidine Hydrochloride Hospira Fresenius Kabi USA
9/21/2015 Benzaclin Clindamycin Phosphate / Benzoyl Peroxide Valeant Perrigo Israel
9/21/2015 Benzamycin Erythromycin / Benzoyl Peroxide Valeant Lyne
9/21/2015 Nexium Esomeprazole Magnesium Astrazeneca Hetero Labs
9/21/2015 Testred Methyltestosterone Valeant Impax Labs
9/21/2015 Lysteda Tranexamic Acid Ferring Pharms Mylan
9/22/2015 Cafcit Caffeine Citrate Eurohealth Intl Aurobindo Pharma
9/22/2015 Ritalin Methylphenidate Hydrochloride Novartis Ascent Pharms
9/22/2015 Roxicodone Oxycodone Hydrochloride Mallinckrodt Epic Pharma
9/23/2015 Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride Ivax Sub Teva Pharms Mirror Pharms
9/24/2015 Focalin Dexmethylphenidate Hydrochloride Novartis Sun Pharm Inds
9/25/2015 Nexium Esomeprazole Magnesium Astrazeneca Dr. Reddy's
9/25/2015 Nexium Esomeprazole Sodium Astrazeneca Accord Healthcare
9/29/2015 Metadate CD Methylphenidate Hydrochloride UCB Mallinckrodt
9/30/2015 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Actavis
9/30/2015 Abilify Aripiprazole Otsuka Apotex
9/30/2015 Dexamethasone Sodium Phosphate Dexamethasone Sodium Prosphate Luitpold BD RX
9/30/2015 Zomig Zolmitriptan IPR MacLeods Pharms
9/30/2015 Zomig Zolmitriptan IPR Alembic Pharms

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.